Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) \[Part 2i\] or mutated EGFR-expression (mutEGFR NSCLC) \[Part 2ii\], squamous NSCLC \[Part 2iii\], GEA \[Part 3\] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive IV ABBV-400 monotherapy in expansion \[Part 4\], participants MET amplification will receive IV ABBV-400 monotherapy in expansion \[Part 5\], participants MET mutation will receive IV ABBV-400 monotherapy in expansion \[Part 6\], participants CRC safety lead in will receive escalating doses of IV ABBV-400 in combination with IV bevacizumab \[Part 7a\], and participants CRC dose optimization in will the low or high dose of IV ABBV-400 determined in Part 7a in combination with IV bevacizumab or oral trifluridine/tipiracil (TAS-102) tablets \[Part 7b\]. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
520
University of California, Los Angeles /ID# 243841
Los Angeles, California, United States
University Of Colorado Denver /ID# 231574
Aurora, Colorado, United States
Yale School of Medicine /ID# 248418
New Haven, Connecticut, United States
University of Illinois Hospital and Health Sciences System /ID# 251386
Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338
Fort Wayne, Indiana, United States
Objective Response Rate (ORR)
ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 48 Months
Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1
DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
Time frame: Up to 48 Months
PFS per RECIST v1.1
Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Time frame: Up to 48 Months
Overall survival (OS)
Overall survival (OS) is defined as time from first study treatment to death due to any cause.
Time frame: Up to 48 Months
Parts 1-6: ORR per Independent Central Review (ICR) in Participants with MET Amplification
ORR defined as percentage of participants with confirmed best overall response of confirmed CR and PR per ICR according to RECIST version 1.1 in participants with MET amplification.
Time frame: Up to 48 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indiana University Melvin and Bren Simon Cancer Center /ID# 245133
Indianapolis, Indiana, United States
Community Health Network, Inc. /ID# 245331
Indianapolis, Indiana, United States
Comprehensive Cancer Centers of Nevada /ID# 242930
Henderson, Louisiana, United States
START Midwest /ID# 231551
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668
New York, New York, United States
...and 72 more locations